Int J Cancer:2005-2010年间FDA和EMA批准的抗癌药物的上市后研究

2017-09-28 MedSci MedSci原创

关于抗肿瘤药上市后的市场营销的研究很少。来自法国的研究人员描述了一组抗癌药物在上市后长期的市场营销情况。

关于抗肿瘤药上市后的市场营销的研究很少。来自法国的研究人员描述了一组抗癌药物在上市后长期的市场营销情况。这是一项横断面研究。2014年9月,研究人员通过clinicaltrials.gov注册确定了在2005-2010年之间获得美国食品和药物管理局和欧洲药品管理局批准上市的新型抗癌药物。所有相关的上市后试验按主治、主要结果、开始日期、赞助者和计划注册分类。研究人员从监管文件中检索补充资料,采用两种方法评价其发表率。十种新型抗癌药物是符合条件的:五种治疗恶性血液病,五种治疗实体癌(其中3种治疗肾癌)。研究人员确定了2345个上市后试验;1362个(58.1%)的主治病症并而不是原来批准那个。研究人员观察到的药物间的极端变化:上市后试验的数量[范围 8-530]和每个试验的总人数[1-8381]。上市后试验的评估几乎包含所有类型的癌症,三个最常研究的癌症是白血病、肾癌和骨髓瘤。最后,6.6%的上市后试验以临床终点为主要结果,35.9%和54.1%分别有安全或替代终点。9种药物获得了补充适应症的批准。依据分析方法,10年的发表率在12.3%到26.1%之间。总之,研究人员发现抗肿瘤药的上市后

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    2017-12-31 1e145228m78(暂无匿称)

    学习了谢谢作者分享!

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    2017-12-28 1e145228m78(暂无匿称)

    学习了谢谢作者分享!

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    2017-09-30 sunylz
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    2017-09-30 fengyi812

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已经多个科研团队发现,正常的细胞可能会无意中释放出一些物质,保护其周边的肿瘤不受抗癌药物的杀伤。这解释了为什么即使是靶向疗法——旨在针对各种癌症背后的具体的基因缺陷的药物——有时也会溃于临门一脚。当在实验室中测试药物对抗孤立的癌细胞的作用时,效果与预期一致。但是,实际的肿瘤由于周围健康的细胞而得到一种天然的保护,药物就可能会失败。

Nat Nanotech:中国药科大张灿教授巧用免疫细胞运输药物,穿透血脑屏障对抗恶性脑瘤

6月19日,中国药科大学的张灿教授团队在《Nature Nanotechnology》期刊发表了最新研究成果,揭示了一种对抗恶性脑瘤的新策略:利用免疫细胞运输抗癌药物,穿透血脑屏障对抗残留肿瘤细胞。这一策略能够抑制肿瘤复发,延长患癌小鼠的寿命。